This project is a quasi-experimental design with one group with pretest-posttest. It is aimed at evaluating the effectiveness of Prazosin in reducing sleep problems in patients with post-stress traumatic disorder. 32 participants are selected among patients with post-stress traumatic disorder, which have sleep problems, according to clinical interview using DSM-IV-TR. They are evaluated with a demographic questionnaire, medical history, the structured interview of CAPS-1, and PCL questionnaire. Their sleep quality and quantity are assessed using Pittsburg sleep quality and Actigraph. The patients take Prazosin in addition to their previous medications. 1 ml g Prazosin is taken 1 hour before sleep, for 3 nights, then 2 ml g for 4 nights. If patient's nightmares were not reduced and there was no side effect, it will be increased to 2 ml g per week, until 10 ml g. If the problem persists, it will be also increased until 15 ml g per week. Then, all the participants will be evaluated according to all the pretests.
General information
Acronym
PTSD
IRCT registration information
IRCT registration number:IRCT2013022512596N1
Registration date:2013-05-07, 1392/02/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-05-07, 1392/02/17
Registrant information
Name
Habiballah Khazaie
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 67 1985 1151
Email address
hkhazaei@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Kermanshah University of Medical Sciences and Health Services
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of Prazosin for sleep problems of patients with post-stress traumatic disorder –chronic, war type
Public title
The effects of Prazosin in treating sleep problems of patients with post-stress traumatic disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients subject to post-stress traumatic disorder chronic war type according to DSM-IV-TR in a clinical interview by a psychiatrist, with sleep problems; Duration of the disorder is more than 6 months; participants' age is between 18 and 60 years (minimum of 18 years as a criterion of adulthood, and 60 years for the practicability of test taking).
Exclusion criteria: history of mania, schizophrenia and other psychotic disorders; depression with suicide ideas; orthostatic hypotension and medicine sensitivity.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for research of Kermanshah University of Medical Sciences and Health Services
Street address
Shahid Beheshti boulevard
City
Kermanshah
Postal code
Approval date
2013-01-16, 1391/10/27
Ethics committee reference number
48649
Health conditions studied
1
Description of health condition studied
sleep problems
ICD-10 code
F51.5
ICD-10 code description
nightmares
2
Description of health condition studied
post traumatic stress disorder
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder
3
Description of health condition studied
sleep problems
ICD-10 code
F51.4
ICD-10 code description
sleep terrors
4
Description of health condition studied
sleep problems
ICD-10 code
G47.0
ICD-10 code description
Disorders of initiating and maintaining sleep [insomnias]
Primary outcomes
1
Description
PTST intensity
Timepoint
the start of the study, two months after the medication started
Method of measurement
the structured interview of CAPS-1
2
Description
sleep problems
Timepoint
the start of the study, two months after the medication started
Method of measurement
the structured interview of CAPS-1, PCL questionnaire, Actigraph
Secondary outcomes
empty
Intervention groups
1
Description
Prazosin prescription: 1 mg 1 hour before sleep for 3 nights, then it increases up to 2 mg for seven nights. In the case of ineffectiveness and lack of counter-indications, the medication increases 2 mg per week until 10 mg, before sleep. The consumption is fixed if the patient report any sign of effectiveness; unless, it increases up to 15 mg per night, in the case of lack of counter-indication.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi hospital
Full name of responsible person
Marzie Nasuri
Street address
Farabi Hospital
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Kermanshah University of Medical Sciences and Health Services
Full name of responsible person
Farabi hospital, Kermanshah university of medical science
Street address
Shahid Beheshti boulevard
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Kermanshah University of Medical Sciences and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah university of medical science
Full name of responsible person
Dr. Habiballah Khazaie
Position
National board of psychiatry
Other areas of specialty/work
Street address
Farabi Hospital
City
Kermanshah
Postal code
6719851151
Phone
+98 83 1826 4512
Fax
Email
hkhazaei@kums.ac.ir
Web page address
kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah university of medical science
Full name of responsible person
Dr. Habiballah Khazaie
Position
National board of psychiatry
Other areas of specialty/work
Street address
Farabi Hospital
City
Kermanshah
Postal code
6719851151
Phone
+98 83 1826 4512
Fax
Email
hkhazaei@kums.ic.ir
Web page address
kums.ic.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah university of medical science
Full name of responsible person
Marzie Nasuri
Position
MSc of Clinical Psychology
Other areas of specialty/work
Street address
Pharabi Hospital, Ashayer BLVRD
City
Kermanshah
Postal code
Phone
00
Fax
Email
marziye_nasori@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)